Clinical Evidence: Eyeaspis DE

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Effect of Oral Re-esterified Omega-3 Nutritional Supplementation on Dry Eyes

Alice T. Epitropoulos et al

Purpose: To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD.

Methods: This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks.

Results: One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (216.8 6 2.6 vs. 29.0 6 2.7 mOsm/L, P = 0.042) and week 12 (219.4 6 2.7 vs. 28.3 6 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P , 0.001) and TBUT (3.5 6 0.5 s vs. 1.2 6 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (217.0 6 2.6) versus control group (25.0 6 2.7, P = 0.002).

Conclusions: Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.

Cornea  Volume 0, Number 0, Month 2016 DOI: 10.1097/ICO.0000000000000940

Efficacy of Omega-3 Fatty Acid Supplementation for Treatment of Dry Eye Disease: A Meta-Analysis of Randomized Clinical Trials

Giuseppe Giannaccare et al

Purpose: To assess whether omega-3 fatty acid (FA) supplementation is more efficacious than placebo in amelioration of signs and symptoms of dry eye disease.

Methods: We performed a systematic literature search in PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials databases. We included randomized clinical trials comparing omega-3 FA supplementation with placebo in patients with dry eye disease. The outcome measures were dry eye symptoms, breakup time (BUT), Schirmer test, and corneal fluorescein staining. The pooled effect sizes were estimated using a random-effects model. Heterogeneity was evaluated using the Q and I2 tests. Sensitivity analysis and assessment of publication bias were performed. Meta-regression was performed to evaluate the source of heterogeneity.

Results: Seventeen randomized clinical trials involving 3363 patients were included. Compared with placebo, omega-3 FA supplementation decreased dry eye symptoms [standardized difference in mean values (SDM) = 0.968; 95% confidence interval (CI) 0.554–1.383; P , 0.001] and corneal fluorescein staining (SDM = 0.517; 95% CI, 0.043–0.991; P = 0.032), whereas it increased the BUT (SDM = 0.905; 95% CI, 0.564– 1.246; P , 0.001) and Schirmer test values (SDM = 0.905; 95% CI, 0.564–1.246; P , 0.001). No evidence of publication bias was observed, and sensitivity analyses indicated the robustness of results obtained. Meta-regression analysis showed a higher improvement of dry eye symptoms and BUT in studies conducted in India.

Conclusions: This meta-analysis provides evidence that omega-3 FA supplementation significantly improves dry eye symptoms and signs in patients with dry eye disease. Therefore, our findings indicate that omega-3 FA supplementation may be an effective treatment for dry eye disease.

Cornea  Volume 38, Number 5, May 2019 DOI:10.1097/ICO.0000000000001884

A Combined Regimen of Dietary Supplements Containing Omega-3 Fish Oil and Standardized Maqui Berry Extract Improves Dry Eye Related Symptoms in a Pilot Randomized Interventional Clinical Study

Edward L Paul Jr |et al

Purpose: To determine if a dietary supplement consisting of a re-esterified triglyceride form of omega-3 fish oil combined with a standardized maqui berry extract is more efficacious for the treatment of dry eye disease than omega-3 fish oil alone.

 Methods: This was an institutional review board-approved, single-site, randomized, interventional, placebocontrolled, comparative, pilot clinical study. Patients with mild to moderate dry eye disease (DED) were enrolled and divided into four study groups. Group 1 (O3M) received dietary supplements of a re-esterified triglyceride form of omega-3 fish oil (O3) and a standardized maqui berry extract (M); group 2 (O3) received only the omega-3 supplements; group 3 (M) received only the maqui berry extract supplements; and group 4 received placebo capsules. Thirteen participants aged 26–78 years with DED were included. Patients were evaluated for DED by corneal staining, changes in tear osmolarity values, matrix metalloproteinase-9 (MMP-9) levels, Schirmer’s test, and tear breakup time (TBUT) at baseline, week 2, week 4, week 8, and a final assessment at week 12. In addition, at each visit patients were given the Ocular Surface Disease Index (OSDI) and Dry Eye questionnaires to complete in order to assess their level of DED. Adverse events (AEs) were recorded on AE forms at each patient visit, and any serious AEs were to be reported to the sponsor within 24 hours via telephone.

Results: 13 patients participated in the study (77% females, 23% males), with an average age of 55 years. The highest average percent improvement in OSDI & DED scores from baseline through week 12 of study treatment was demonstrated in the O3M group (77.6% and 70.5% respectively), compared to 39.2% improvement in OSDI assessment and 44.9% in DED score for the O3 group. Schirmer’s tests demonstrated an average increase in tear production over baseline of ~3.4 mm in OD and ~0.8 mm in OS after 3 months for the O3M group. In comparison, for the O3 group, the tear production decreased by ~0.6 mm in OD and increased by ~1.67 mm in OS from baseline to 3 months. TBUT improved significantly in the O3M group, from baseline to 3 months it went up by ~3.2-2.8 sec in both eyes (OD & OS), while for the O3 group TBUT values went up by ~1.66-2.0 sec in both eyes (OD&OS). Notably, there were no adverse events reported due to dietary supplement usage during the study.

Conclusion: Dietary supplements of omega-3 fish oil and standardized maqui berry extract outperformed omega-3 fish oil alone as a treatment for DED.

Paul Jr et al., J Clin Exp Ophthalmol 2019, 10:2 DOI: 10.4172/2155-9570.1000795

Impact of oral vitamin D supplementation on the ocular surface in people with dry eye and/or low serum vitamin D

Chih-Huang Yang et al

Purpose: To determine the possible association between serum vitamin D levels and dry eye symptoms, and the impact of an oral vitamin D supplement.

Methods: Three linked studies were performed. (i) 29 older adult participants, (ii) 29 dry eyed participants, and (iii) 2-month vitamin D supplementation for 32 dry eyed/low serum vitamin D levelled participants. All participants were assessed by the Ocular Surface Diseases Index (OSDI) to determine dry eye symptoms, and the phenol red thread test (PRT) and/or Schirmer’s tear test, tear meniscus height, non-invasive tear break up time, grading ocular surface redness and fluorescein staining of the cornea to detect the tear quality and ocular surface conditions. Blood samples were collected for serum vitamin D analysis and interleukin-6 (IL-6) levels.

Results: Among older adult participants, vitamin D levels were negatively correlated with dry eye symptoms, the severity of dry eye, and associated with tired eye symptom. Vitamin D levels of people with dry eye diagnosis were not correlated with OSDI scores and IL-6 levels; while IL-6 levels showed correlation with tear production. In supplement study, vitamin D levels increased by 29 mol/l, while dry eye symptoms and grading of corneal staining appeared significant reductions. No significant changes in IL-6 levels.

Conclusions: Low vitamin D levels (< 50 nmol/l) were associated with dry eye symptoms in older individuals but not those diagnosed with dry eye. Vitamin D supplement increased the vitamin D levels, and improved dry eye symptoms, the tear quality and ocular surface conditions.

1367-0484/ © 2017 Published by Elsevier Ltd on behalf of British Contact Lens Association.

Effects of MaquiBright® on improving eye dryness and fatigue in humans: A randomized, double-blind, placebo-controlled trial

Shin-ichiro Yamashita et al.

Purpose: This study aims to investigate the effects of MaquiBright®, also known as BrightSight®, a standardized maqui berry extract, on improving eye dryness and fatigue in Japanese subjects (aged 30-60 years) experiencing eye dryness, eye fatigue, and ≥4 h of visual display terminal (VDT) work daily.

Methods: Seventy-four participants were equally but randomly assigned to either a MaquiBright® (MB) or a placebo (P) group, wherein each participant consumed one capsule daily for 4 weeks of the appropriate treatment (MaquiBright® 60 or 0 mg). Eye dryness and fatigue were measured using the Schirmer’s test, tear break-up time (BUT) test, pupillary response, and flicker test before intake and 4 weeks after intake. Furthermore, subjective symptoms were assessed using the Visual Analogue Scale (VAS) method and the Dry Eye-related Quality of Life Score (DEQS) questionnaire.

Results: The MB group demonstrated a significantly higher lacrimal fluid production in both eyes (increased 6.4 ± 8.1 mm, P ¼ 0.005) in Schirmer’s test compared to the P group before VDT load (playing a video game) at 4 weeks after intake. In the VAS method after VDT load, the reduction of subjective symptoms in eye fatigue (P ¼ 0.047) and stiff shoulders (P ¼ 0.035) were significantly higher in the MB group than in the P group as well as bother-some ocular symptoms (P ¼ 0.037) by the DEQS. No adverse events were reported. Thus, the con-sumption of 60 mg of MaquiBright® per day for 4 weeks reduced eye dryness and seemed to alleviate eye fatigue.

Conclusions: This study deduces that the consumption of MaquiBright® (BrightSight®, 60 mg/day) for 4 weeks alleviated eye dryness and most likely relieved eye fatigue in 30- to 60-year-old healthy participants. Overall, MaquiBright® was found to be safe for consumption under the study conditions.

Shin-ichiro Yamashita et al., Journal of Traditional and Complementary Medicine 9 (2019) 172-178

Effects of Oral Vitamin B1 and Mecobalamin on Dry Eye Disease

Xiaotong Ren et al.

Purpose: To assess the effects of oral vitamin B1 and mecobalamin on dry eye disease (DED) and patient satisfaction with treatment.

 Methods:  In this randomized controlled study, DED patients were divided into 4 groups based on treatment: group 1, only artificial tears; group 2, corticosteroid eye drops and artificial tears; group 3, oral vitamin B1, mecobalamin, and artificial tears; and group 4, oral vitamin B1, mecobalamin, corticosteroid eye drops, and artificial tears. DED symptoms, signs, and patient satisfaction with treatment were assessed at baseline and at 1 and 2 months after treatment.

 Results: In total, 152 eyes from 76 patients (age, 55.25 ± 18.16 years) were included. In group 3, there were significant differences in dryness, foreign body sensation, burning, and tear film breakup time first (TBUTF) between 1 and 2 months after treatment and in satisfaction scores before and after treatment (P < 0.05). In group 3, there were also significant differences in dryness, foreign body sensation, photophobia, and TBUTA and between baseline and 2 months after treatment (P < 0.05). There was a significant difference in foreign body sensation between 1 and 2 months after treatment in groups 3 and 4 (P < 0.05). Furthermore, we also find obvious improvement in corneal nerve fiber density (CNFD) between baseline and 1 and 2 months after treatment in groups 3 and 4 (P < 0.05).

Conclusions:  Oral vitamin B1 and mecobalamin can relieve some dry eye symptoms such as dryness, pain, and photophobia and improve DED signs and patient satisfaction. Thus, vitamin B1 and mecobalamin are potential treatment options for patients with DED.

Xiaotong Ren et al., Hindawi Journal of Ophthalmology Volume 2020, Article ID 9539674